Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

This study has been terminated.
(A review of blinded data indicates that the number of patient exposures needed to reach ICH standards has been met)
Information provided by (Responsible Party):
Cubist Pharmaceuticals Holdings LLC Identifier:
First received: September 21, 2012
Last updated: February 3, 2015
Last verified: February 2015

The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Condition Intervention Phase
Opioid-Induced Constipation
Drug: CB-5945
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain

Resource links provided by NLM:

Further study details as provided by Cubist Pharmaceuticals Holdings LLC:

Primary Outcome Measures:
  • Safety and Tolerability of CB-5945 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    The Safety and Tolerability of CB-5945 will be evaluated 0.25 mg twice a day (BID) over 12 months, relative to placebo

    Incidence of adverse events and serious adverse events

Secondary Outcome Measures:
  • Mean daily opioid dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life (QOL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The evaluation of the effects of CB-5945 on quality of life (QOL) measurements relative to placebo

  • Constipation severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of the effects of CB-5945 on constipation severity relative to placebo

  • Plasma Trough Concentrations of CB-5945 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determination of the plasma trough concentrations of CB-5945.

Enrollment: 1407
Study Start Date: October 2012
Study Completion Date: October 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CB-5945 Drug: CB-5945
0.25 mg CB-5945 BID for 52-week treatment period
Other Name: Bevenopran
Placebo Comparator: Placebo Drug: Placebo
Placebo BID for 52-week treatment period

Detailed Description:

This is a multicenter, double-blind, placebo-controlled, parallel-group study in subjects with OIC taking opioid therapy for chronic non-cancer pain. Approximately 1,400 subjects (approximately 700 subjects per treatment group) with OIC will be randomized at approximately 225 study centers to receive either 0.25 mg CB-5945 BID or a matching placebo BID for the 52-week double-blind treatment period, followed by a 4-week follow-up period. All randomized subjects will be evaluated for safety, tolerability, and quality of life from the first dose of study medication through Week 56.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Is taking a stable daily dose of opioids of ≥ 30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
  2. Has constipation that is caused by the chronic use of opioids
  3. Is willing to use only the study-provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) during the study period (from Screening until the last study assessment).
  4. Is able and willing to refrain from facilitating defecation via manual maneuvers (e.g., digital evacuation, support of the pelvic floor) from Screening to the last study assessment

Exclusion Criteria:

  1. Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (e.g., obstruction) or contribute to bowel dysfunction
  2. Has evidence of intestinal obstruction
  3. Has a history of rectal bleeding not due to hemorrhoids or fissures
  4. Has an active malignancy of any type (subjects with a history of successfully treated malignancy > 5 years before the scheduled administration of study medication and subjects with treated basal or squamous cell cancer may be enrolled)
  5. Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
  6. Is taking nonopioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01696643

  Show 152 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals Holdings LLC
Study Director: Medical Monitor Cubist Pharmaceuticals Holdings LLC
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals Holdings LLC Identifier: NCT01696643     History of Changes
Other Study ID Numbers: 5945-SOIC-12-05
Study First Received: September 21, 2012
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals Holdings LLC:

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on August 27, 2015